BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROSORBA COLUMN

    MDR report key: 694091 · Received March 29, 2006

    Report

    Report Number
    3032792-2006-00002
    Event Type
    Other
    Date Received
    March 29, 2006
    Date of Event
    February 23, 2006
    Report Date
    March 29, 2006
    Manufacturer
    FRESENIUS HEMOCARE
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RA PT DEVELOPED CHILLS WITH TEMP TO 103.8 F ADTER 2ND TREATMENT. SHE WAS ADMITTED TO THE HOSP FOR EVALUATION. PERIPHERAL ACCESS WAS USED FOR TREATMENT. ALL CULTURES CAME BACK WITH NO GROWTH. PT DISCHARGED AFTER THREE DAYS. NO CAUSE FOUND. SHE DECIDED NOT TO CONTINUE PROSORBA COLUMN TREATMENT. NO FURTHER INFO HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN IMMUNOABSORPTION COLUMN LQQ FRESENIUS HEMOCARE 9798701 RDN001E

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization